PerCara Original Medicated Powder

Dosage form: powder
Ingredients: Menthol 0.1g in 100g, Zinc Oxide 1g in 100g
Labeler: Willard Manufacturing Inc.
NDC Code: 67933-0003

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS:

Active ingredient:                   Purpose 

Menthol 0.1%..................................Anti-Itch

Zinc oxide 1.0%..............................Skin Protectant


USE for the temporary relief of pain and itching due to:

- minor cuts   - sun burn  - insect bites  - poison ivy  - poison oak
- poison sumac  - scrapes  - minor burns  - minor skin irritations

Dries the oozing and weeping of:

- poison ivy  - poison oak  - poison sumac

Warnings For external use only

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When using this product avoid contact with eyes
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Stop use and ask a doctor if condition worsens, or if symptoms persist for
more than 7 days or clear up and occur again within a few days
-----------------------------------------------------------------------------------------------
Keep our of reach of children.  If swallowed, get medical help or contact a
Poison Control Center right away.

When using this product avoid contact with eyes
-----------------------------------------------------------------------------------
Stop use and ask a doctor if condition worsens, or if symptoms persist for
more than 7 days or clear up and occur again within a few days

Warnings For external use only

Directions

- adults and children 2 years of age and older:  apply to affected area not

  more than 3 to 4 times daily

- children under 2 years of age:  do not use, consult a doctor

- For best results dry skin thoroughly before applying

Inactive ingredients

talc, salicylic acid, boric acid, zinc stearate, thymol, eucalyptol

PERCARA ORIGINAL MEDICATED POWDER 
menthol, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67933-0003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol0.1 g  in 100 g
Zinc Oxide (Zinc Oxide) Zinc Oxide1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Talc 
Salicylic Acid 
Boric Acid 
Zinc Stearate 
Thymol 
Eucalyptol 
Packaging
#Item CodePackage Description
1NDC:67933-0003-1283 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34808/22/2012
Labeler - Willard Manufacturing Inc. (208799143)
Registrant - Willard Manufacturing Inc. (208799143)
Establishment
NameAddressID/FEIOperations
Willard Manufacturing Inc.208799143manufacture(67933-0003)

Revised: 08/2012
 
Willard Manufacturing Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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